The Safe Step Act amends the Employee Retirement Income Security Act of 1974 (ERISA) to require group health plans and health insurance issuers to implement a clear, prompt, and transparent exceptions process for medication step therapy protocols. This process enables participants, beneficiaries, or their prescribing healthcare providers to request coverage for a non-preferred drug without first trying alternative, preferred medications. The bill aims to prevent unnecessary delays in accessing appropriate treatments by providing a structured pathway for exceptions. The legislation outlines specific circumstances under which an exception must be granted, such as when prior treatments have been ineffective , a delay in treatment would lead to severe or irreversible consequences , or if required treatments are contraindicated or likely to cause adverse reactions. It also covers situations where the required treatment prevents maintaining functional ability or if the patient is already stable on the requested drug . The process must allow prescribers to present clinical rationale and medical information, using standard forms, and avoid requesting unnecessary documentation. To ensure timely access, the bill sets strict deadlines for processing these requests: 72 hours for standard requests and an expedited 24-hour review for urgent cases where delay could seriously jeopardize a patient's life or health. Approved exceptions must last at least one year. Furthermore, the Act mandates annual reporting by health plans to the Secretary of Labor on exception requests, approvals, denials, and appeals, with the Secretary providing a public summary to Congress.
The Safe Step Act amends the Employee Retirement Income Security Act of 1974 (ERISA) to require group health plans and health insurance issuers to implement a clear, prompt, and transparent exceptions process for medication step therapy protocols. This process enables participants, beneficiaries, or their prescribing healthcare providers to request coverage for a non-preferred drug without first trying alternative, preferred medications. The bill aims to prevent unnecessary delays in accessing appropriate treatments by providing a structured pathway for exceptions. The legislation outlines specific circumstances under which an exception must be granted, such as when prior treatments have been ineffective , a delay in treatment would lead to severe or irreversible consequences , or if required treatments are contraindicated or likely to cause adverse reactions. It also covers situations where the required treatment prevents maintaining functional ability or if the patient is already stable on the requested drug . The process must allow prescribers to present clinical rationale and medical information, using standard forms, and avoid requesting unnecessary documentation. To ensure timely access, the bill sets strict deadlines for processing these requests: 72 hours for standard requests and an expedited 24-hour review for urgent cases where delay could seriously jeopardize a patient's life or health. Approved exceptions must last at least one year. Furthermore, the Act mandates annual reporting by health plans to the Secretary of Labor on exception requests, approvals, denials, and appeals, with the Secretary providing a public summary to Congress.